Wanted to give 6 little tidbits on vaccines: 1) Know U.S. roll-out has been slower and I think will start becoming faster now after holiday 2) Designs of all 3 trials summarized before (Pfizer/BioNtech, Moderna, AztraZeneca) has primary outcome of preventing symptomatic disease &
secondary outcome of preventing severe infection. All 3 performed well, meaning almost ALL of the severe infections were in placebo arms. That is goal - to prevent what is scary about #COVID-19, severe outcomes 3) Pfizer/BioNtech vaccine needing -70 C temps slowing roll-out
Moderna likely to hasten roll-out 4) AztraZeneca data (with weekly swabbing) indicates that vaccines prevent asymptomatic transmission as well so unlikely to spread it after vax 5) Makes sense vaccines will prevent asymptomatic & symptomatic disease as antibodies/T-cells
should block viral entry as well as symptomatic disease 6) Some states vaccinating older>essential workers; may depend on age distribution in state; point of vaccinating essential workers first is to get society functioning Teacher/worker who gets vaccine should feel safe working
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Since the UK just approved the AstraZeneca/University of Oxford COVID-19 vaccine today, I wanted to summarize the results of the interim analysis of their Phase 3 trials published in Lancet on December 8 with some slides: thelancet.com/journals/lance…
Back to testing and the paper from my excellent colleagues at UCSF! Mass testing campaign- Among 3,302 persons tested for SARS-CoV-2 by rapid antigen (BinaxNOW) & RT-PCR, rapid assay sensitivity 100% using RT-PCR Ct thresholds of 30- specificity 99.9%. pubmed.ncbi.nlm.nih.gov/33367619/
This think is SUCH an important pivotal paper! Discussion "SARS-CoV-2 pandemic control calls for fast, low-barrier, high-performing field assays.. US has purchased 150 million BinaxNOWTM cards, yet ..use to date has been limited.. our data show that these tests are readily ..."
deployed in a field setting at scale for children & adults.. can rapidly identify persons with high levels of virus including thosewho are asymptomatic..leading to immediate public health action". Okay so if this has a very low false positive rate (0.01%) and high sensitivity
Have been musing on ACIP recs all day. To be clear, 1a is health care workers & long-term care facilities (maybe 5 weeks); 1b is those >75 yrs and front-line essential workers (firefighters/police; teachers; food & agriculture like processing plants/farm labor; public transit,
grocery store, postal service, correction workers, manufacturing (out to 10 weeks maybe but 1c will start before); 1c is those 65-74 years; those 16-64 years with high-risk conditions (on other CDC website listed as cancer, chronic kidney disease, COPD, heart conditions, organ
transplant, obesity, sickle cell disease, smoking, pregnancy, type II diabetes); and essential workers not represented in 1b (transportation, food service, construction, finance, IT and communications, energy, media, legal, public safety, water/wastewater); phase 2- all else
The U.S. has been the epicenter of the pandemic since March 26, since two weeks after COVID-19 was declared a pandemic by the WHO on March 11. This is due to failed federal response, but not all because of that but because of structure of this country, which fractures responses
and decisions to counties/states/local levels. Everyone had different responses but we are all connected so one response affects another. Also, we failed to protect workers &poor so when openings occurred or even during shutdown, people of course had to work to survive
These weaknesses of our system will hopefully be strengths when it comes to vaccine distribution as that is the only way to get out of this now and local/state/counties distributing will hopefully be effective. Remember, #Moderna vaccine had 36.5% representation from communities
More on #vaccines e.g. the full report on the Moderna vaccine which is likely to be authorized this week! By the way, there was a ? asked about vials of the Pfizer vaccine being fuller than one dose. FDA says "At this point, it is acceptable to use every full dose obtainable"
So, if each pack is 5 doses with 5 vials but you can get a 6th or 7th dose out of a vial because they are highly filled, do it, says FDA (could mean we could have 40% more doses than we thought although company may cut back from overfilling).
In terms of #Moderna vaccine, the full FDA brief was released yesterday and the meeting is tomorrow. Brief is here. fda.gov/media/144434/d…. I put the data into these few slides which I will now upload as pictures.
My concern about the almost-complete lockdown order in 5 counties in Bay Area is that it is similar to March, but we have learned so much about the virus since March! In March, a complete lockdown was indicated because we didn’t know if the virus was spread from surfaces;
we didn’t know if it was spread from asymptomatic individuals (it is); we essentially treated the infection as if it was radioactive. At this point, we have learned a lot about how to mitigate spread, including masks, distancing, ventilation and hand hygiene.
Therefore, to institute the same measures as in March, including shutting down of playgrounds (despite lack of evidence on surface transmission), outdoor dining (where there has been no data to show that this is unsafe), and prohibiting members of different households to gather